A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Virgo
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia
1 other identifier
interventional
230
1 country
23
Brief Summary
Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States. Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days. There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2021
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedStudy Start
First participant enrolled
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2022
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 21, 2023
March 1, 2023
5 months
July 22, 2021
February 6, 2023
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.
3 hours after second dose on Day 14
Secondary Outcomes (3)
Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
Study Arms (2)
Vehicle
PLACEBO COMPARATORParticipants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.
AGN-190584
EXPERIMENTALAGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.
Interventions
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
Eligibility Criteria
You may qualify if:
- \- Objective and subjective evidence of presbyopia.
You may not qualify if:
- Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity.
- Narrow iridocorneal angles (Shaffer grade \<=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy.
- Diagnosis of any type of glaucoma or ocular hypertension.
- History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
- Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (23)
Empire Eye and Laser /ID# 231433
Bakersfield, California, 93309-0637, United States
Global Research Management /ID# 231300
Glendale, California, 91204-2500, United States
United Medical Research Institute /ID# 233982
Inglewood, California, 90301, United States
North Valley Eye Medical Group, Inc. /ID# 231270
Mission Hills, California, 91345-1200, United States
The Eye Research Foundation /ID# 231274
Newport Beach, California, 92663-3637, United States
Martel Eye Medical Group /ID# 231332
Rancho Cordova, California, 95670-2968, United States
Nature Coast Clinical Research - Crystal River /ID# 231298
Crystal River, Florida, 34429, United States
Bruce Segal, MD /ID# 231413
Delray Beach, Florida, 33484-6540, United States
Clayton Eye Clinical Research, LLC /ID# 231243
Morrow, Georgia, 30260-4180, United States
Jacksoneye, SC /ID# 231374
Lake Villa, Illinois, 60046-8563, United States
Price Vision Group /ID# 231261
Indianapolis, Indiana, 46260-5381, United States
Kannarr Eye Care /ID# 231363
Pittsburg, Kansas, 66762-2620, United States
Cincinnati Eye Institute- Edgewood /ID# 231356
Edgewood, Kentucky, 41017-3415, United States
The Eye Care Institute /ID# 231275
Louisville, Kentucky, 40206-1738, United States
Rochester Ophthalmological Group PC /ID# 231371
Rochester, New York, 14618-2616, United States
Southern College of Optometry /ID# 231325
Memphis, Tennessee, 38104-2211, United States
Total Eye Care, PA /ID# 231245
Memphis, Tennessee, 38119-5745, United States
Advancing Vision Research /ID# 231244
Smyrna, Tennessee, 37167, United States
Hill Country Eye Center /ID# 231293
Cedar Park, Texas, 78613-7651, United States
The Cataract & Glaucoma Center /ID# 231292
El Paso, Texas, 79902-1444, United States
Eye associates /ID# 231262
San Antonio, Texas, 78229, United States
Hoopes, Durrie, Rivera Research /ID# 231273
Draper, Utah, 84020-7133, United States
Country Hills Eye Center /ID# 231414
Ogden, Utah, 84403-2200, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2021
First Posted
July 30, 2021
Study Start
September 2, 2021
Primary Completion
February 11, 2022
Study Completion
February 11, 2022
Last Updated
March 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.